Reported Jul 2, 2014 · Terminated
LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that…
Lap of America Laser Applications, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: LAP of America Laser Applications, LLC · 161 Commerce Rd Ste 3 · Boynton Beach, FL · 33426-9385
Is this the product you have?
- LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.
- Lot codes and dates
- Product Code0007569-0001
- Amount recalled
- 1 system
Where it was sold
Why it was recalled
While projecting yellow lines it was notice that the yellow projection has the potential to splits into two separate red and green projections. In this case the difference between the red and green projection was up to 2.5mm.
This product could cause temporary or reversible health problems — stop using it.
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